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Clinical Innovative Drug Project
  • New drug
  • Indication
  • Preclinical
  • IND
  • Clinical Phase I
  • Clinical Phase II
  • Clinical Phase III
  • NDA
  • X-396 Ensartinib (China)

    lung cancer

    Description

    Ensartinib (X-396) is a novel, potent and highly selective next-generation inhibitor of anaplastic lymphoma kinase (ALK), which has a potency more than ten-times greater than crizotinib in enzymatic assays. Ensartinib targets ALK, inhibiting downstream malignant pathways that contribute to tumorigenesis and disease progression. Ensatinib has shown good efficacy in in vitro and in vivo studies, including those tumors that are already resistant to clozatinib, and has inhibitory effects on c-Met, TRK 1/ 2/ 3, ROS1, etc. A phase II trial has evaluated the efficacy, safety, and biomarkers of ensartinib in crizotinib-resistant, ALK-positive non-small-cell lung cancer. The drug registration application of ensatinib hydrochloride for patients with advanced crizotinib-resistant, ALK-positive non-small-cell lung cancer has been accepted, and it has been included in the list of priority review varieties by the State Food and drug administration.

    Indication

    lung cancer

  • Vectibix Panitumumab

    colorectal cance

    Description

    Vectibix is an all human anti epidermal growth factor receptor monoclonal antibody (IgG2) developed by Amgen, which is mainly used for targeted treatment of RAS wild-type patients with advanced colorectal cancer. Approved by the United States for the first time in September 2006, it has been listed in 77 countries around the world. At present, 6000 clinical trial subjects and 280000 post marketing patients have been treated with panitumumab. Betta has signed a joint venture with Amgen to introduce panitumumab to be listed in China, which is currently being promoted.

    Indication

    colorectal cance

  • MIL60 Bevacizumab

    lung cancer, colorectal cancer

    Description

    MIL60 is a targeted antibody drug for human vascular endothelial growth factor (VEGF). It is a bevacizumab biosimilar, which can be used to treat non-small cell lung cancer, colorectal cancer and other solid tumor indications. MIL60 can inhibit tumor angiogenesis by inhibiting the binding of VEGF and VEGFR, so as to cut off tumor feeding and prevent tumor growth. A phase III clinical trial is evaluating the first-line treatment of MIL60 combined with carboplatin and paclitaxel in advanced, metastatic or recurrent NSCLC.

    Indication

    lung cancer, colorectal cancer

  • X-396 Ensartinib (Global)

    lung cance

    Description

    Ensartinib (X-396) is a novel, potent and highly selective next-generation inhibitor of anaplastic lymphoma kinase (ALK), which has a potency more than ten-times greater than crizotinib in enzymatic assays. Ensartinib targets ALK, inhibiting downstream malignant pathways that contribute to tumorigenesis and disease progression. Ensatinib has shown good efficacy in in vitro and in vivo studies, including those tumors that are already resistant to clozatinib, and has inhibitory effects on c-Met, TRK 1/ 2/ 3, ROS1, etc. A phase III head to head trial is evaluating ensartinib as the first-line treatment in patients with ALK-positive non-small cell lung cancer as compared with crizotinib.

    Indication

    lung cance

  • CM082 Vorolanib

    renal cell carcinoma

    Description

    Vorolanib (CM082) is a novel next-generation of multi-target kinase inhibitor, which can inhibit tumor angiogenesis and growth, and can be used in the treatment of many kinds of cancer. Vorolanib has a significant anti-angiogenic effect on VEGFR, PDGFR, c-Kit, Flt-3, CSF1R and other multiple targets, and the special PK/PD of vorolanib can preserve activity and reduce toxicity. A phase II/III clinical trial (CONCEPT) is evaluating vorolanib in combination with everolimus in the treatment of patients with advanced renal cell carcinoma.

    Indication

    renal cell carcinoma

  • CM082 Vorolanib

    melanoma

    Description

    Vorolanib (CM082) is a novel next-generation of multi-target kinase inhibitor, which can inhibit tumor angiogenesis and growth, and be used in the treatment of many kinds of cancer. Toripalimab (JS001) is a new type of recombinant humanized anti-PD-1 monoclonal antibody, which was approved by National Medical Products Administration in China on December 17, 2018, and used for locally progress or metastatic melanoma after previous standard treatment failure. A phase II trial is evaluating the vorolanib in combination with the toripalimab for the treatment of patients with locally progress or metastatic melanoma.

    Indication

    melanoma

  • BPI-D0316

    lung cancer

    Description

    BPI-D0316 is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) for T790M mutation. Epidermal growth factor receptor (EGFR) is the main driving factor of non-small cell lung cancer. EGFR-TKIs can inhibit tumor cells via specifically inhibiting the EGFR activity. At present, first-generation of EGFR-TKIs are the mainly treatments of EGFR mutant non-small cell lung cancer. However, patients often progressed within a certain period of time duo to acquired resistance, of which T790M mutation accounts for more than 60%. Studies have shown that the third-generation EGFR-TKIs for T790M mutation can significantly improve the life quality the overall survival of patients with non-small cell lung cancer. BPI-D0316 has performed well in phase I clinical trials in China, and a phase II clinical trials have been launched.

    Indication

    lung cancer

  • CM082 Vorolanib

    wet age-related macular degeneration

    Description

    Vorolanib (CM082) is a novel next-generation of multi-target kinase inhibitor, which can inhibit tumor angiogenesis and growth, and can be used in the treatment of many kinds of cancer. Vorolanib has a significant anti-angiogenic effect on VEGFR, PDGFR, c-Kit, Flt-3, CSF1R and other multiple targets, and the special PK/PD of vorolanib can preserve activity and reduce toxicity. A phase II clinical trial is evaluating vorolanib in the treatment of patients with wet age-related macular degeneration, and patients showed well tolerance and significant visual improvement.

    Indication

    wet age-related macular degeneration

  • BPI-3016

    Diabetes mellitus II

    Description

    BPI-3016 is a novel diabetes drug independently developed by Betta. It is the first super long-term glucagon like peptide-1 (GLP-1) analogue obtained by structural modification of the main chain of natural GLP-1 in China. BPI-3016 retains the multiple effects of natural GLP-1, and overcomes its easily degradable characteristics. It not only has good biological activity, but also can reduce body weight and improve the function of β cells. Meanwhile, BPI-3016 has good subcutaneous absorption and long half-life, supporting the design expectation of weekly administration with good safety. It has unique advantages in the treatment of type II diabetes as well as prevention and treatment of cardiovascular risk. At present, clinical research is being promoted.

    Indication

    Diabetes mellitus II

  • BPI-16350

    breast cancer

    Description

    BPI-16350 is a novel antitumor drug independently developed by Betta. It is a cyclin dependent kinase CDK4 and CDK6 inhibitor with new structure. CDK4/6 are the key factors to regulate cell cycle, which can trigger cell cycle transition from G1 phase to S phase. BPI-16350 can specifically combine with CDK4/6 to inhibit the kinase activity, inhibit the proliferation, metastasis and other related signal transduction of cancer cells, block the cell cycle in G1 phase, thus inhibiting the proliferation of tumor cells. The clinical trial of BPI-16350 in breast cancer has been approved and is now ongoing.

    Indication

    breast cancer

  • BPI-23314

    solid tumors, hematological malignancies

    Description

    BPI-23314 is a novel molecular compound independently developed by Betta with completely independent intellectual property rights. It is a potent and highly selective bromodomain and extra-terminal domain (BET) oral small molecule inhibitor. BPI-23314 can specifically inhibit the function of BET family proteins, regulate the transcription and expression of cancer-related genes, and then affect cell growth, proliferation, apoptosis and other physiological processes, thus inhibiting tumor growth. The clinical trial of BPI-23314 has been approved and is now ongoing.

    Indication

    solid tumors, hematological malignancies

  • BPI-17509

    solid tumors

    Description

    BPI-17509 is a novel, potent and highly selective small molecule oral inhibitor of fibroblast growth factor receptor (FGFR1/2/3) independently developed by Betta. It is intended to be used in various tumor therapies with FGFR gene. FGFR plays an important role in tumor proliferation, angiogenesis, migration and survival. BPI-17509 can specifically inhibit the activity of FGFR1/2/3, block the related signal transduction pathway, and then affect several physiological processes such as cell proliferation, apoptosis, migration, neovascularization in vivo, thus inhibiting tumor growth. The clinical trial application of BPI-17509 has been approved and is now ongoing.

    Indication

    solid tumors

  • MRX2843

    solid tumors, hematological malignancies

    Description

    MRX2843 is a novel, potent,  and bioavailable small-molecule oral inhibitor, which is a dual inhibitor of MERTK and FLT3. MERTK and FLT3 are overexpressed or mutated in a variety of tumors. MRX2843 can affect tumor growth by inhibiting MERTK and FLT3 in tumor cells and innate immune cells in tumor microenvironment, thereby affecting the key signal transduction pathways or immunomodulation to inhibit tumors. The clinical trial of MRX2843 for advanced solid tumor has been approved, and it is ongoing.

    Indication

    solid tumors, hematological malignancies